Evaluation of the Building Healthy Life Skills Program

NCT05611060 | Unknown Phase 2

• 1 other identifier: Cameron2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this intervention trial is to learn test whether participation in the Building Health Life Skills Program leads to improvements in psychological well-being and stress management skills for people who are experiencing homelessness and housing insecurity. The main questions it aims to answer are:

• Will participation in the Building Healthy Life Skills Program lead to better skills in managing negative emotions?
• Will participation in the Building Healthy Life Skills Program lead to improvements in psychological well-being, sleep quality, and health-related quality of life? Participants will be asked to complete three surveys: one prior to the first session of the program, one at the end of the program, and one three months later. The surveys include measures of skills for managing negative emotions, mood states, sleep quality, health-related quality of life, illness experiences, and history of childhood adversity.

Conditions

Adverse Childhood Experiences; Housing Problems; Emotion Regulation

Outcome Measures

Primary Outcomes (11)

• Change in health-related quality of life as assessed by the SF-12, for which scores range from 0 to 100 with higher scores reflecting better quality of life

  Health-related quality of life as assessed by the SF 12

  Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion

• Change in depressive symptoms as assessed by the Center for Epidemiological Studies Depression measure, for which averaged rating scores range from 0 to 3 with higher scores reflecting more depressive symptoms

  Scores on the Center for Epidemiological Studies Depression measure

  Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion

• Change in stress as assessed by the Perceived Stress Scale, for which averaged rating scores range from 1 to 5 with higher scores reflecting greater stress

  Scores on the Perceived Stress Scale

  Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion

• Change in rumination as an emotion regulation behavior as assessed by the Rumination and Reflections Questionnaire,for which averaged rating scores range from 1 to t with higher scores reflecting more rumination

  Scores on the Rumination and Reflections Questionnaire

  Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion

• Change in emotional suppression as assessed by the Cortauld Emotional Control Scale (scores range is 1-4, higher scores reflect higher suppression) and the Emotion Regulation Questionnaire (scores range is 1-5, higher scores reflect higher suppression)

  Scores on the Cortauld Emotional Control Scale and the Emotion Regulation Questionnaire

  Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion

• Change in mindfulness as an emotional regulation tendency as assessed by the Mindful Awareness Attention Scale, for which averaged rating scores range from 1 to 5 with higher scores reflecting greater mindfulness tendencies

  Scores on the Mindful Awareness Attention Scale

  Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion

• Change in cognitive reappraisal as an emotion regulation strategy as assessed by the Emotion Regulation Questionnaire, for which averaged rating scores range from 1 to 5 with higher scores reflecting higher use of cognitive reappraisal

  Scores on the Emotion Regulation Questionnaire

  Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion

• Change in general self-efficacy as assessed by the General Self-Efficacy Survey, for which averaged rating scores range from 1 to 5 with higher scores reflecting higher sense of self-efficacy in managing challenging situations

  Scores on the General Self-Efficacy Survey

  Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion

• Change in resilience as assessed by the Ego Resilience 89, for which averaged rating scores range from 1 to 5 with higher scores reflecting higher resilience in managing challenging situations

  Scores on the Ego Resilience 89

  Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion

• Change in sleep quality as assessed by the Pittsburgh Sleep Quality Inventory, for which averaged rating scores range from 0 to 21 with higher scores reflecting poorer sleep quality

  Scores on the Pittsburgh Sleep Quality Inventory

  Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion

• Change in physical health as assessed by self-reported number of sick days in the past month (ranging from 0 to 31) and a the frequency of 17 symptoms each rated 1 to 5 and higher averaged rating scores reflecting higher symptom loads

  Scores on a symptom checklist and number of sick days

  Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion

Interventions

Building Healthy Life Skills Program BEHAVIORAL

The intervention provides education and training in the long-term mental and physical health consequences of childhood adversity and emotion regulation skills.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who are receiving support services from the Merced County Navigation Center due their current experiences of housing insecurity or homelessness, and
• have enrolled in the Building Healthy Life Skills program

You may not qualify if:

• Individuals under the age of 18 years and those who cannot speak English or Spanish

Sponsors & Collaborators

• University of California, Merced: lead

Study Sites (1)

University of California Merced

Merced, California, 95343, United States

RECRUITING

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Central Study Contacts

Linda D Cameron, Ph.D.

CONTACT

209-626-6892; lcameron@ucmerced.edu

Marisela Yepez, B.S.

CONTACT

209-228-2252; myepez5@ucmerced.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The study utilizes a pretest-posttest design, with surveys completed at baseline immediately prior to the start of the intervention onset, immediately after completion of the intervention, and at follow-up 3 months after the completion of the intervention.

Study Record Dates

• First Submitted: October 29, 2022
• First Posted: November 9, 2022
• Study Start: October 10, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: November 9, 2022

Record last verified: 2022-11

Locations

US (1)